Feasibility and metabolic effects of carbohydrate loading in patients with fragility hip fracture - a randomised double blind pilot study

ISRCTN	ISRCTN91109766
DOI	https://doi.org/10.1186/ISRCTN91109766
Secondary identifying numbers	16941

Submission date: 04/07/2014
Registration date: 04/07/2014
Last edited: 12/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Iain Moppett
Scientific

Department of Anaesthesia and Intensive Care
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Email	iain.moppett@nottingham.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified, Prevention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Feasibility and metabolic effects of carbohydrate loading in patients with fragility hip fracture - a randomised double blind pilot study
Study acronym	Pre-operative Nutrition In Neck of femur Trial (POINT)
Study objectives	Hip fracture is a common injury affecting predominantly old people. The outcome for patients is often poor with a high mortality following operation, and worsening of mobility and function when compared with that before the injury.It has long been recognized that trauma due to surgery or accident is associated with changes in the way muscles use fuels such as sugar (glucose). These changes come on soon after injury and persist for some time and may have harmful effects on recovery and muscle strength. We also know that poor muscle function is a predictor of poor outcome in the days and months following hip fracture. Researchers in the field of elective surgery have found that providing patients with special carbohydrate drinks before their operation can improve muscle sugar use and have beneficial effects in the postoperative period.However, due to the nature of hip fracture, which is operated on urgently, and in a frail population who are often in pain, providing preoperative drinks may be difficult. The muscle of older people behaves differently to that of younger people so we don't know whether these drinks will have the same effect. Potentially, if we can find out what effect these drinks have on the way muscles behave; this may provide avenues of future research into the optimal way to enhance muscle function following hip fracture. To do this, we wish to study a group of hip fracture patients. We wish to find out what happens to the way their bodies deal with sugar if they have these drinks or if they have normal care without the drinks. We would do this by simple blood tests, and by taking some small tissue samples from leg muscles before and after their operation. Part of the study will also be looking at the practical issues around providing these sorts of drinks to this patient group.
Ethics approval(s)	East Midlands - Nottingham 1 Research Ethics Committee, 15/07/2013, ref: 13/EM/0214
Health condition(s) or problem(s) studied	Enhancement of recovery following hip fracture surgery
Intervention	Pre-op carbohydrate drink, Nutricia Pre-op(r) 400 ml night before surgery 400 ml morning of surgery (up to 2 hours pre-op) Follow Up Length: 1 month(s); Study Entry: Single Randomisation only
Intervention type	Procedure/Surgery
Primary outcome measure	Oral glucose tolerance test; Timepoint(s): Day 1 post operation
Secondary outcome measures	1. Glucose homeostasis - blood glucose; Timepoint(s): Blood glucose prior to induction of anaesthesia 2. Blood glucose on day 1; Glucose homeostasis - insulin; Timepoint(s): Insulin concentration - prior to induction of anaesthesia, Insulin concentration - day 1 post op 3. Length of acute hospital stay; Timepoint(s): Hospital discharge 4. Mobility - Cumulated ambulation score; Timepoint(s): Days 1-3 post-op 5. Muscle metabolism - muscle biopsy, contralateral leg; Timepoint(s): Prior to induction of anaesthesia At end of surgery Day 1 6. Nausea and vomiting; Timepoint(s): Prior to induction of anaesthesia Day 1 post-operation
Overall study start date	01/07/2014
Completion date	31/08/2015

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Planned Sample Size: 30; UK Sample Size: 30; Description: Allow for 3 drop outs per group (20% drop out)
Key inclusion criteria	1. Patients presenting through accident and emergency with a fragility neck of femur fracture requiring hemiarthroplasty 2. Aged 70 or over 3. Patients able to provide fully informed consent
Key exclusion criteria	1. Patients who are confused or unable to give their own consent 2. Patient known to suffer with diabetes (either type 1 or type 2) 3. Patients with current infections 4. Ongoing participation in another clinical trial 5. Multiple injuries requiring operative management 6. Previous intolerance to carbohydrate drinks
Date of first enrolment	01/07/2014
Date of final enrolment	31/08/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queens Medical Centre

Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Research organisation

British Journal of Anaesthesia (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	04/12/2014		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

12/08/2020: No publications found.
13/03/2020: Internal review.
21/11/2018: No publications found, verifying study status with principal investigator.